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PharmaCompass offers a list of Desmopressin Acetate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Desmopressin Acetate manufacturer or Desmopressin Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Desmopressin Acetate manufacturer or Desmopressin Acetate supplier.
PharmaCompass also assists you with knowing the Desmopressin Acetate API Price utilized in the formulation of products. Desmopressin Acetate API Price is not always fixed or binding as the Desmopressin Acetate Price is obtained through a variety of data sources. The Desmopressin Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Adiuretin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Adiuretin, including repackagers and relabelers. The FDA regulates Adiuretin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Adiuretin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Adiuretin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Adiuretin supplier is an individual or a company that provides Adiuretin active pharmaceutical ingredient (API) or Adiuretin finished formulations upon request. The Adiuretin suppliers may include Adiuretin API manufacturers, exporters, distributors and traders.
click here to find a list of Adiuretin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Adiuretin DMF (Drug Master File) is a document detailing the whole manufacturing process of Adiuretin active pharmaceutical ingredient (API) in detail. Different forms of Adiuretin DMFs exist exist since differing nations have different regulations, such as Adiuretin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Adiuretin DMF submitted to regulatory agencies in the US is known as a USDMF. Adiuretin USDMF includes data on Adiuretin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Adiuretin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Adiuretin suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Adiuretin Drug Master File in Japan (Adiuretin JDMF) empowers Adiuretin API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Adiuretin JDMF during the approval evaluation for pharmaceutical products. At the time of Adiuretin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Adiuretin suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Adiuretin Drug Master File in Korea (Adiuretin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Adiuretin. The MFDS reviews the Adiuretin KDMF as part of the drug registration process and uses the information provided in the Adiuretin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Adiuretin KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Adiuretin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Adiuretin suppliers with KDMF on PharmaCompass.
A Adiuretin CEP of the European Pharmacopoeia monograph is often referred to as a Adiuretin Certificate of Suitability (COS). The purpose of a Adiuretin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Adiuretin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Adiuretin to their clients by showing that a Adiuretin CEP has been issued for it. The manufacturer submits a Adiuretin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Adiuretin CEP holder for the record. Additionally, the data presented in the Adiuretin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Adiuretin DMF.
A Adiuretin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Adiuretin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Adiuretin suppliers with CEP (COS) on PharmaCompass.
A Adiuretin written confirmation (Adiuretin WC) is an official document issued by a regulatory agency to a Adiuretin manufacturer, verifying that the manufacturing facility of a Adiuretin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Adiuretin APIs or Adiuretin finished pharmaceutical products to another nation, regulatory agencies frequently require a Adiuretin WC (written confirmation) as part of the regulatory process.
click here to find a list of Adiuretin suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Adiuretin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Adiuretin API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Adiuretin as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Adiuretin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Adiuretin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Adiuretin suppliers with NDC on PharmaCompass.
Adiuretin Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Adiuretin GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Adiuretin GMP manufacturer or Adiuretin GMP API supplier for your needs.
A Adiuretin CoA (Certificate of Analysis) is a formal document that attests to Adiuretin's compliance with Adiuretin specifications and serves as a tool for batch-level quality control.
Adiuretin CoA mostly includes findings from lab analyses of a specific batch. For each Adiuretin CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Adiuretin may be tested according to a variety of international standards, such as European Pharmacopoeia (Adiuretin EP), Adiuretin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Adiuretin USP).